Evidence map›Paper›PMID 36650502›Full record

ArticleBMC psychiatry2023

Design and rationale of the REStoring mood after early life trauma with psychotherapy (RESET-psychotherapy) study: a multicenter randomized controlled trial on the efficacy of adjunctive trauma-focused therapy (TFT) versus treatment as usual (TAU) for adult patients with major depressive disorder (MDD) and childhood trauma.

Anouk W Gathier, Josine E Verhoeven, Patricia C van Oppen, Brenda W J H Penninx, Maarten J M Merkx, Pieter Dingemanse, Kim M K S Stehouwer, Carmen M M van den Bulck, Christiaan H Vinkers

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05149352 (REStoring Mood After Early Life Trauma), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05149352 naunknown statusnot on this map

REStoring Mood After Early Life Trauma: the Effectiveness of Trauma-focused Therapy in Patients With Depression and Childhood Trauma

TypeinterventionalSponsorAmsterdam UMC, location VUmcRan2021 to 2024Enrolled158ConditionsMajor Depressive Disorder, Childhood TraumaArmsTreatment as usual (TAU) for depression, Trauma-focused therapy (TFT)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Anouk W GathierAmsterdam UMC Location Vrije Universiteit Amsterdam, Department of Psychiatry, Boelelaan 1117, Amsterdam, The Netherlands. a.w.gathier@amsterdamumc.nl.
Josine E VerhoevenAmsterdam UMC Location Vrije Universiteit Amsterdam, Department of Psychiatry, Boelelaan 1117, Amsterdam, The Netherlands.
Patricia C van OppenAmsterdam UMC Location Vrije Universiteit Amsterdam, Department of Psychiatry, Boelelaan 1117, Amsterdam, The Netherlands.
Brenda W J H PenninxAmsterdam UMC Location Vrije Universiteit Amsterdam, Department of Psychiatry, Boelelaan 1117, Amsterdam, The Netherlands.
Maarten J M MerkxHSK, NL Mental Health Care Group, Steijnlaan 12, Hilversum, The Netherlands.
Pieter DingemanseAltrecht GGZ, Nieuwe Houtenseweg 12, Utrecht, The Netherlands.
Kim M K S StehouwerHSK, NL Mental Health Care Group, Steijnlaan 12, Hilversum, The Netherlands.
Carmen M M van den BulckAltrecht GGZ, Nieuwe Houtenseweg 12, Utrecht, The Netherlands.
Christiaan H VinkersAmsterdam UMC Location Vrije Universiteit Amsterdam, Department of Psychiatry, Boelelaan 1117, Amsterdam, The Netherlands.
Altrecht GGZ · NLAmsterdam University Medical Centers · NLGGD Amsterdam · NLGGZ inGeest · NLPublic Health Service of Amsterdam · NL

Funding

Stichting tot Steun Vereniging tot Christelijke Verzorging van Geestes- en Zenuwzieken 272
6 · The paper itself

Abstract

backgroundMajor depressive disorder (MDD) is a common, recurrent mental disorder and a leading cause of disability worldwide. A large part of adult MDD patients report a history of childhood trauma (CT). Patients with MDD and CT are assumed to represent a clinically and neurobiologically distinct MDD subtype with an earlier onset, unfavorable disease course, stress systems' dysregulations and brain alterations. Currently, there is no evidence-based treatment strategy for MDD that specifically targets CT. Given the central role of trauma in MDD patients with CT, trauma-focused therapy (TFT), adjunctive to treatment as usual (TAU), may be efficacious to alleviate depressive symptoms in this patient population.

methodsThe RESET-psychotherapy study is a 12-week, single-blind, randomized controlled trial testing the efficacy of TFT in 158 adults with moderate to severe MDD, as a 'stand-alone' depression diagnosis or superimposed on a persistent depressive disorder (PDD), and CT. TFT (6-10 sessions of Eye Movement Desensitization and Reprocessing and/or imagery rescripting) + TAU is compared to TAU only. Assessments, including a wide range of psychological/psychiatric and biological characteristics, take place before randomization (T0), during treatment (T1), at post-treatment (T2) and at 6-month follow-up (T3). Pre-post treatment stress-related biomarkers in hair (cortisol) and blood (epigenetics and inflammation) will be assessed to better understand working mechanisms of TFT. A subgroup of 60 participants will undergo structural and functional Magnetic Resonance Imaging (MRI) assessments to determine pre-post treatment brain activity. The primary outcome is self-reported depression symptom severity at post-treatment, measured with the 30-item Inventory of Depressive Symptomatology - Self Report (IDS-SR). DISCUSSION: If adjunctive TFT efficaciously alleviates depressive symptoms in MDD patients with CT, this novel treatment strategy could pave the way for a more personalized and targeted MDD treatment.

trial registrationClinicalTrials.gov, registered at 08-12-2021, number of identification: NCT05149352.

Indexed as

Adverse Childhood ExperiencesMajor Depressive DisorderAdultAffectHumansMulticenter Studies as TopicPsychotherapyRandomized Controlled Trials as TopicSingle-Blind MethodTreatment OutcomeChildhood TraumaEye Movement Desensitization and ReprocessingImagery RescriptingMajor Depressive DisorderRandomized Controlled TrialTrauma-Focused Therapy

Identifiers

PMID36650502
PMCPMC9843991
OpenAlexW4316670130

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.